Live Online Training: Confidence in Analytical Results and Measurement Uncertainty

Live Online Training: Confidence in Analytical Results and Measurement Uncertainty

Course No 19228

All times mentioned are CEST

Costs

ECA-Member: EUR 890,--
Regular Fee: EUR 990,--
EU/GMP Inspectorates: EUR 495,--
APIC Member Discount: EUR 950,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Objectives

In this new online Training Course, the principles of measurement uncertainty and error budgets will be discussed. You will get to know how to apply these principles in your analytical laboratory. The purpose of course is to
  • Describe the basic principles of measurement uncertainty and error budgets
  • Apply these basic principles to the calibration and qualification of analytical instruments
  • Allow participants to gain experience in applying the techniques to analytical method validation and method transfer.
  • Introduce the Monte Carlo simulation approach for more complex systems

Background

For many years, measurement uncertainty calculations have been a requirement in ISO 17025 accredited laboratories.  The USP has introduced these ISO concepts into USP General Chapter <1010> Analytical Data—Interpretation And Treatment.  Measurement uncertainty is of key importance in analytical instruments qualification as well as in analytical methods validation and transfer. Therefore everyone who is involved in generating and evaluating analytical results in GMP controlled laboratories or bears the responsibility for these activities must have a thorough understanding of the principles of measurement uncertainty and error budgets.

Target Group

This training is recommended for Laboratory Managers, Supervisors and Analysts in pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures as well as the Calibration and Qualification of Analytical Instruments. Furthermore, this Course will be of interest to personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Introduction to the Course

Basics of Measurement Uncertainty
  • Definition of measurement and uncertainty
  • Analytical Procedures (Methods) as Processes
  • Error sources and statistical descriptions
  • Accuracy and Trueness under ISO definitions
  • ICH Q2(R1) and revision in 2021 to (R2) & Q14
  • Approaches to quantifying MU and Error Budgets
  • Quantifying uncertainties with a very simple example; a reference standard solution
  • Shape of errors
  • Statistical assumptions for Error budgets
Measurement Uncertainty in Calibration and Qualification of Analytical Instrumentation
  • Qualification, Calibration & Validation (QCV)
  • Experimental Errors
  • Calibration example of a UV spectrophotometer
    • Wavelength accuracy
    • Sensitivity; DL & QL
Measurement Uncertainty in the Validation of Analytical Methods
  • Holistic approach of MU
  • Case study example; Error Budget Process
  • Step 1: Description of the measurement process
  • Step 2: Specification of the measurand
  • Step 3: Identification of uncertainty sources
  • Steps 4 & 5: Quantification and combination of uncertainties
Measurement Uncertainty without the Maths; an Introduction to Monte Carlo Simulation
  • Monte Carlo Simulation (MCS) modelling
  • Principles behind MCS for MU
  • Example 1: Making a standard solution of a certified reference material (CRM)
  • Example 2: Leachable cadmium determination by Atomic Absorption Spectrometry (AAS)
  • Pros & Cons for MCS
Method Transfer; Success or Failure?
  • Case Study with interactive workshop
Process Performance and Reportable Values
  • What is a reportable value?
  • OOS, OOE & OOT
  • Process performance and process capability
  • ICH precision approach
  • USP <1010>

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